Regulatory Chemist
Decatur Memorial Hospital - Decatur, IL

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Bachelor's Degree
  • Job Description: Regulatory Chemist

    Zevacor Molecular is a pharmaceutical company, affiliated with a $500 Million, 3000 employee healthcare system. Zevacor develops and manufactures radiology drug products under current Good Manufacturing Practices (cGMP) conditions and in accordance with FDA regulatory guidelines, 21 CFR Part 211 and 212.

    Target Candidate

    We are looking for high-energy, high-talent people interested in being part of a rapidly growing company serving the radiopharmaceutical segment of the healthcare industry. The successful candidate will have good interpersonal abilities with particularly strong written communication skills. The candidate will be based in Indianapolis. Significant travel to various drug production facilities located throughout the U.S. is required

    This person will be a key participant in the development and submission of Abbreviated New Product Applications (ANDAs) and Investigatory New Drug Applications (INDs). He or she will work closely with a team of people, including nuclear pharmacists and production technicians on site, as well as contracted experts in cyclotron and drug synthesis manufacturing. The objective of this team will be to commission, qualify, and operate radioactive drug production activities for a portfolio of generic or investigatory new drugs under 21 CFR Part 211 or Part 212. This person will be responsible for developing the methods for conducting QC protocols on PET drug products, as well as the implementation and commissioning of these methods on the analytical instruments, such as GC, HPLC, and TLC analyzers. Once commissioned, this person will be actively involved in supporting the production team to ensure that the QC equipment is properly maintained, calibrated and qualified.

    This person must be experienced in working with a variety of chemistry and biochemistry analytical systems used for testing chemicals, reagents, precursors, and final drug products; such as Gas Chromatography, Ion Chromatography and HPLC Analyzers among others. BA/BS in biochemistry, chemistry, or biology is required with 3 or more years of industry experience required working in manufacturing, quality control, and/or an analytical laboratory. Experience working in the pharmaceutical industry with adherence to cGMP is preferred.

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